Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.
Heart Center Bad Segeberg, Segeberger Kliniken GmbH, Bad Segeberg, Germany.
Clin Res Cardiol. 2023 Sep;112(9):1278-1287. doi: 10.1007/s00392-023-02205-4. Epub 2023 Apr 16.
Patients with atherothrombotic risk are at high hazard of ischemic events. Preventive medicine plays a major role in modifying their outcomes. Whether the choice of a BP-SES or DP-EES can contribute to the occurrence of events remains unclear. We sought to investigate the outcomes of patients with higher atherothrombotic risk (H-ATR) versus lower atherothrombotic risk (L-ATR) undergoing percutaneous coronary intervention (PCI) with either bioresorbable-polymer sirolimus-eluting stent (BP-SES) or durable-polymer everolimus-eluting stent (DP-EES).
Patients (n = 2361) from BIOFLOW-II, -IV, and -V randomized trials were categorized into H-ATR vs. L-ATR. L-ATR patients had ≤ 1 and H-ATR ≥ 2 of the following criteria: presentation in ACS, diabetes mellitus, previous myocardial infarction, previous PCI/CABG, or previous stroke. Endpoints were target lesion failure (TLF: cardiac death, target-vessel myocardial infarction [TV-MI], target lesion revascularization [TLR]) and stent thrombosis (ST) at three years.
H-ATR patients (n = 1023) were more morbid than L-ATR patients (n = 1338). TLF rate was significantly higher in H-ATR patients as compared with L-ATR (11.6% vs. 7.0%; HR 1.67, 95% CI 1.27-2.20, p < 0.0001). With BP-SES TLF rates were numerically lower as compared with DP-EES in H-ATR (10.5% vs. 13.5%; HR 0.78, 95% CI 0.54-1.14, p = 0.20) and significantly lower in L-ATR (5.6% vs. 9.8%; HR 0.57, 95% CI 0.38-0.85, p = 0.006).
In the era of newer-generation DES, patients with H-ATR still are at hazard for ischemic events. Patients with BP-SES had lower TLF rates as compared with DP-EES, most consistent in L-ATR whereas in H-ATR patients most probably secondary preventive strategies are of higher value.
Clinicaltrial.gov. NCT01356888, NCT01939249, NCT02389946. https://clinicaltrials.gov/show/NCT01356888 , https://clinicaltrials.gov/show/NCT01939249 , https://clinicaltrials.gov/show/NCT02389946 .
患有动脉血栓形成风险的患者发生缺血事件的风险很高。预防医学在改变他们的预后方面起着重要作用。使用生物可吸收聚合物西罗莫司洗脱支架（BP-SES）或耐用聚合物依维莫司洗脱支架（DP-EES）是否会导致事件发生仍不清楚。我们旨在研究更高动脉血栓形成风险（H-ATR）与较低动脉血栓形成风险（L-ATR）的患者接受经皮冠状动脉介入治疗（PCI）时的结局，这些患者分别使用生物可吸收聚合物西罗莫司洗脱支架（BP-SES）或耐用聚合物依维莫司洗脱支架（DP-EES）。
来自 BIOFLOW-II、-IV 和 -V 随机试验的患者（n=2361）被分为 H-ATR 与 L-ATR。L-ATR 患者符合以下标准中的≤1 个：ACS 发作、糖尿病、既往心肌梗死、既往 PCI/CABG 或既往中风。终点为靶病变失败（TLF：心脏死亡、靶血管心肌梗死[TV-MI]、靶病变血运重建[TLR]）和支架血栓形成（ST）三年。
H-ATR 患者（n=1023）比 L-ATR 患者（n=1338）病情更严重。与 L-ATR 患者相比，H-ATR 患者的 TLF 发生率显著更高（11.6% vs. 7.0%；HR 1.67，95%CI 1.27-2.20，p<0.0001）。与 DP-EES 相比，H-ATR 患者使用 BP-SES 的 TLF 发生率略低（10.5% vs. 13.5%；HR 0.78，95%CI 0.54-1.14，p=0.20），在 L-ATR 中则显著更低（5.6% vs. 9.8%；HR 0.57，95%CI 0.38-0.85，p=0.006）。
在新一代 DES 时代，H-ATR 患者仍面临缺血事件的风险。与 DP-EES 相比，BP-SES 患者的 TLF 发生率更低，在 L-ATR 中更为一致，而在 H-ATR 患者中，二级预防策略可能更有价值。
Clinicaltrial.gov。NCT01356888、NCT01939249、NCT02389946。https://clinicaltrials.gov/show/NCT01356888、https://clinicaltrials.gov/show/NCT01939249、https://clinicaltrials.gov/show/NCT02389946。
